MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INNOVA VASCULAR; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	26926
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an innova self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed a kink at the nose cone.Microscopic examination revealed no additional damages.The stent was deployed and did not return with the device.There is blood present on the device.The guide wire used in the clinical procedure was not returned with the device so a test guide wire was used for functional testing.Per product specification, a device to device interaction test was performed with a.035 guidewire.An amplatz super stiff.035 guidewire was used, and the guidewire could pass through the entire device.Some resistance was felt at the kink at the nose cone.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis could not confirm the froze on wire but did confirm some resistance at the kink.
Event or Problem Description
It was reported that the innova delivery system was stuck on the wire.A magic torque guidewire and a 7x150x130 innova vascular stent were selected for a stent procedure in the superficial femoral artery (sfa).During the procedure, there was difficulty advancing the innova device.The innova stent was deployed safely into the patient.The delivery system was difficult to remove and became stuck on the magic torque guidewire.Everything was removed together.The physician lost wire position.There were no patient complications.

• Brand Name: INNOVA VASCULAR
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8433889
• Report Number: 2134265-2019-02703
• Device Sequence Number: 11028557
• Product Code: NIP
• UDI-Device Identifier: 08714729874133
• UDI-Public: 08714729874133
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/11/2021
• Device Model Number: 26926
• Device Catalogue Number: 26926
• Device Lot Number: 0021974773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 03/19/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MAGIC TORQUE GUIDEWIRE